| CTRI Number |
CTRI/2025/01/079615 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the safety and tolerability of VISPO in healthy adult human subjects |
|
Scientific Title of Study
|
An Open labelled study to assess the safety and tolerability of VISPO (standardized saw palmetto oil) in healthy adult human subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VH/RD/CH/02, Version 1.1 dated 14 NOV 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Vidyasagar |
| Designation |
Asst. Professor-InCharge-Nephrology Unit |
| Affiliation |
Government Medical College & Government General Hospital (Old RIMSGGH) |
| Address |
Department of Medicine,
Government Medical College & Government General Hospital (Old RIMSGGH)
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9491191631 |
| Fax |
|
| Email |
gghsrikakulam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep |
| Designation |
Research Scientist |
| Affiliation |
Vidya Herbs Pvt Ltd |
| Address |
Department of Biomedicinal Research
No.14A, KIADB Industrial Area, Jigani 1st Phase, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
09620384780 |
| Fax |
|
| Email |
research@vidyaherbs.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep |
| Designation |
Research Scientist |
| Affiliation |
Vidya Herbs Pvt Ltd |
| Address |
Department of Biomedicinal Research No.14A, KIADB Industrial Area, Jigani 1st Phase, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
09620384780 |
| Fax |
|
| Email |
research@vidyaherbs.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Private Limited
Vidya Building, N3-3 24th Main
JP Nagar, 1st Phase, Bangalore - 560 078, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Building, N3-3 24th Main
JP Nagar, 1st Phase, Bangalore - 560 078
Karnataka, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Vidyasagar |
Government Medical College & Government General Hospital (Old RIMSGGH) |
OPD 13, First Floor, Department of General Medicine,
Government Medical College & Government General Hospital (Old RIMSGGH)
Srikakulam
ANDHRA PRADESH |
9499191631
gghsrikakulam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Government General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not Applicable |
| Intervention |
VISPO capsule |
4 capsules after breakfast, 2 capsules after lunch, and 4 capsules after dinner, daily for duration of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male volunteers aged 40-70 years.
2. Body Mass Index (BMI) between 18.5 and 24.9 kg/m².
3. Stable medication regimen for at least 3 months prior to the study (if applicable).
4. Agrees to comply with the study protocol and procedures.
5. Agrees to not participate in any other clinical trials during the course of this trial.
6. Willing to participate in the study and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to fish oil or astaxanthin.
2. Current use of other investigational drugs.
3. Use of omega-3 supplements or astaxanthin supplements within 4 weeks prior to the study.
4. Significant liver or renal disease.
5. History of major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months.
6. Active malignancy or history of cancer within the last 5 years.
7. Pregnant or lactating women and women of childbearing potential not following adequate contraceptive measures or women who were found positive for urine pregnancy test.
8. Participation in another clinical trial within 30 days prior to study entry. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in safety parameters including Complete Blood Count (CBC), Blood biochemistry, Lipid profile, Liver Function Tests (LFT) and Renal Function Tests (RFT) |
Day 1, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Change in vital signs parameters |
Day 1, Day 14, Day 28 |
| 2) Assessment of tolerability, incidence and severity of adverse events |
Day 1, Day 14, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is designed to assess the safety and
tolerability of VISPO in three visits and assessments includes
the evaluation of adverse events and laboratory tests to monitor CBC, blood
biochemistry, lipid profile, LFT and RFT. |